Sacubitril/Valsartan Versus Valsartan in Heart Failure
- Conditions
- Heart Failure
- Interventions
- Registration Number
- NCT05881720
- Lead Sponsor
- Damanhour University
- Brief Summary
The objective of this study was to identify potential prognostic factors of sacubitril/valsartan vs Valsartan treatment response.
- Detailed Description
Study will include 80 symptomatic patients with chronic HFrEF (left ventricular ejection fraction ≤35%) and New York Heart Association (NYHA) class II/III: Group 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) or group 2 received valsartan (target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment. Analysis of biochemical parameters, cardiopulmonary exercise testing, and echocardiographic evaluation was performed at baseline and 6 months later. The primary outcome was the change in LVEF%, Lipo A, troponin I, NT-Pro BNP and neopterin levels. The secondary outcome is reporting efficacy and safety of sacubitril/valsartan vs Valsartan use and the relationship between NYHA and EF and biomarkers.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Patients with HF were enrolled if aged > 35 years,
- Stable symptomatic systolic chronic HF (≥ 4 weeks), with left ventricular ejection fraction (LVEF) < 35%,
- NYHA class II-III,
- Sinus rhythm and resting HR ≥ 70 beats/min on optimised standard medical therapy.
- Patients with acute decompensation,
- Cerebrovascular events during the previous 6 months,
- Pregnancy, breastfeeding,
- Any valve dysfunction/abnormality,
- Active myocarditis,
- Second-degree and third-degree atrioventricular block,
- Sick sinus syndrome.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 (N = 40) Sacubitril / Valsartan Oral Tablet Group 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) in addition to recommended therapy according to physician's judgment. Group 2 (N = 40) Valsartan 80 mg group 2 received valsartan (target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment.
- Primary Outcome Measures
Name Time Method LVEF % 6 months left ventricular ejection fraction percent
Lipo A (pg/ml) 6 months Lipo protien A (pg/ml)
Troponin.I (ng/ml) 6 months Troponin.I (ng/ml) biomarker
NT-Pro BNP 6 months NT-pro BNP(pg/ml) biomarker
Neopterin (nmol/l) 6 Months Neopterin biomarker
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Tanta University Hospital
🇪🇬Tanta, Elgarbia, Egypt